Approval · Notice of Compliance 2041 · 1999
ZOCOR: Notice of Compliance 2041
Issued September 2, 1999
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 2041
- Date
- September 2, 1999
- Company
- Merck Frosst Canada Inc.Kirkland, QC, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Revised indications: 1. reduce the risk of fatal plus non-fatal cerebrovascular events (stroke and transient ischemic attacks); 2. reduce the risk of major coronary events in hypercholesterolemic patients with diabetes mellitus
- Therapeutic class
- Lipid metabolism regulator
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ZOCOR | Not yet assigned | — |
Medicinal ingredients
- SIMVASTATIN 5 MG per TAB
- SIMVASTATIN 10 MG per TAB
- SIMVASTATIN 20 MG per TAB
- SIMVASTATIN 40 MG per TAB
- SIMVASTATIN 80 MG per TAB